CMC Program Lead

This is a fully remote position, open to applicants in United States, +4 more countries.

📋 Description

• Lead the CMC Sub-Team and act as the primary point of contact for all CMC-related matters concerning the TLX597 and TLX66 programs.

• Formulate, implement, and uphold integrated CMC strategies and plans that span from preclinical development through to Phase 3.

• Collaborate with functional Subject Matter Experts (SMEs) across Drug Substance, Drug Product, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Validation, and Regulatory CMC.

• Oversee CMC deliverables, timelines, budgets, risk registers, decision logs, project dashboards, and Gate-readiness packages.

• Monitor deliverables across multiple concurrent projects and manage relationships with internal and external partners, including contracts, budgets, and invoices.

• Identify CMC-related risks, formulate mitigation strategies, and escalate issues proactively.

• Provide consistent CMC updates to senior management and program governance teams.

• Coordinate with manufacturing sites and external Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs) for the supply of Drug Substance and Drug Product.

• Collaborate with R&D, Discovery, Translational Development, Radiochemistry, Regulatory, Quality, Supply Chain, and partner organizations.

• Support CMC Investigational New Drug (IND) packages, clinical supply workstreams, technology transfer packages, and transitions between phases.

• Organize meetings and maintain agendas, minutes, decision logs, task lists, and risk analyses.

• Detect process gaps and implement solutions in alignment with Standard Operating Procedures (SOPs) and relevant Good Practices (GxP) requirements.

⛳️ Requirements

• A Bachelor's degree in Science, Mathematics, Engineering, or a related scientific field is required.

• Over 10 years of pertinent experience in radiopharmaceutical, pharmaceutical, or biopharma CMC.

• At least 5 years of experience in CMC program or project management.

• Required experience with biologics, monoclonal antibodies, bioconjugates, and/or radiopharmaceuticals.

• Proven experience managing pharmaceutical alliance or partnership programs, or executing multi-site CMC operations within a matrix structure.

• In-depth understanding of FDA and global regulatory standards, including IND and NDA/BLA requirements pertinent to radiopharmaceuticals and biologics.

• Technical knowledge of antibody manufacturing, upstream and downstream processing, bioconjugation, radiochemistry, and drug product fill/finish.

• Acquainted with ICH Q8-Q12 guidelines and Quality by Design principles, encompassing Target Product Profiles (TPPs), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and control strategy development.

• Strong project management skills throughout the drug development lifecycle.

• Experience in a successful matrix-managed environment.

• Capacity to demonstrate initiative and enhance or establish processes.

• Ability to thrive in a dynamic, fast-paced, and continuously evolving global environment with minimal supervision.

• Willingness to travel occasionally to manage collaborations with global team members and CDMOs.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development initiatives.

• Competitive salary package.

• Options for hybrid and remote work arrangements.